Drilling depth and control apparatus and methods for using the same

ABSTRACT

This disclosure relates to drill guides and depth control apparatus for use with a variety of customized or standardized surgical instruments. In embodiments, the apparatus comprises at least a body portion and a collar portion, one or more of which are configured to be coupled to a cutting instrument, such as a drill bit, in a specified location and manner to prevent unwanted movement. In embodiments, the assembly of the body and collar portions may be incrementally adjusted to alter the desired depth of the cutting instrument. Methods for using the foregoing apparatus are also disclosed herein.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 17/156,330 filed on Jan. 22, 2021, now issued U.S. Pat. No.11,529,147, which in turn claims the benefit of and priority to U.S.Provisional Patent Application No. 62/706,296 filed on Aug. 7, 2020pursuant to 35 U.S.C. § 119(e). Each of these applications areincorporated by reference herein in their entirety.

FIELD

The present disclosure relates to the field of medical devicesgenerally. More specifically, the present disclosure relates to cuttingapparatus and depth control apparatus for use with a variety ofcustomized or standardized surgical instruments. Methods for using theforegoing apparatus and devices also disclosed herein.

BACKGROUND

Many prior art devices used to achieve various drilling tasks or relatedactivities suffer from significant disadvantages, such as poor stabilityand/or accuracy, difficulty in handling and operating in confinedspaces, poor visibility, multiple components that require timelyassembly/disassembly and inventory management, and other disadvantages.For example, many drilling apparatus have fast moving parts, rotatingparts and/or vibrating parts which prevent the drilling apparatus to besecured in a comfortable and fixed position while in use or whichsignificantly impair the visibility and operation of the operable end ofthe apparatus. Furthermore, prior art drilling apparatus have little orno depth control or accuracy measures with respect to over-drilling orunder-drilling, as the application may tend to require. As an example,during drilling, much of the prior art may cause the drill to plungedeeper into the patient if the depth control apparatus becomes unsecureor unlocks. These problems and shortcomings are even more noticeablewhen considering prior art drills for use in surgical settings or whichotherwise require a high degree of precision.

In addition to the shortcomings with drilling apparatus, fixationdevices can also suffer from various shortcomings. For example, pedicleand other types of surgical screws are subject to relatively highfailure rates, which is often attributed to a failure of the bone-screwinterface. Screws for use in surgical settings may also be limited foruse in only certain boney anatomies, specific bone densities, specifictrajectories, or with only certain types of drilling apparatus. Toaddress these and other shortcomings, many surgeons use patient-specificapparatus to assist with surgical procedures, in part to ensure accuracyand in part to address the many variables and inherent differences inanatomical features from one patient to the next. U.S. patentapplication Ser. No. 16/831,215 is incorporated by reference herein forthe purpose of describing patient-specific apparatus used in surgicalsettings.

Accordingly, there is a need for an apparatus that improves the accuracyand efficacy of surgical instruments, such as drilling instruments,enhances depth control and stability when performing drillingoperations, and which otherwise overcomes the disadvantages of the priorart. In particular, there is a need for an apparatus that may be safely,securely and selectively attached to an instrument prior to a drillingoperation, for example, and which may be customized or preconfigured tothe particular patient anatomy to be operated on for safe depth control.

There is also a strong need for an apparatus that improves patientsafety during drilling or cutting procedures, in part by controlling theamount of boney purchase during certain surgical procedures requiringthe use of drilling or cutting apparatus. For example, in posterior openspinal procedures it is advantageous to control the depth of drilling tothe extent where a small anterior breach is achieved in the Sacrum inorder to obtain stronger bi-cortical purchase at the sacral promontory.In other areas, an anterior breach is quite dangerous and controllingthe depth of a cutting apparatus to prevent a breach may also beadvantageous.

The prior art also fails to teach a system for creating a suite ofsurgical apparatus based on the data set derived from a patient's MRI orCT scan. For example, the availability of patient-specific data (forexample, a vertebral body) may allow a surgeon to accommodate for subtlevariations in the position and orientation of an instrument, such as adrill bit or screw, to avoid particular boney anatomy, or irregularitiesin the positioning and alignment of the adjoining vertebral bodies. Asanother example, the use of patient data may also assist a surgeon inselecting a desired trajectory or depth of an implantable device so asto avoid, for example, crossing the pedicle wall and violating thespinal canal during a spine-related procedure. The use ofpatient-specific data permits the surgeon to avoid these types ofmistakes by creating and utilizing customized apparatus, which maycomprise specific end-stops/hard stops, or other safety related featuresto avoid over-torque or over-insertion of an associated device. Thisdata also permits the surgeon to create a patient-specific apparatusthat are oriented to match one or more of the anatomical featuresderived from the data set, and thereby quickly and efficiently locateand place devices with corresponding patient-contacting surface(s) inthe appropriate location and orientation.

It would therefore be advantageous to provide apparatus suitable for usewith a surgical procedure that is adapted and/or configured and/orcapable of conforming to a plurality of anatomical features of aparticular patient, and/or to one or more additional apparatus to assistthe surgeon in completing the surgical procedure(s) safely andefficiently, and that otherwise significantly reduces, if noteliminates, the problems and risks noted above. Other advantages overthe prior art will become known upon review of the Summary and DetailedDescription.

SUMMARY

Embodiments of the present disclosure provide systems, methods, anddevices for enhancing surgical procedures, such as drilling operations,including but not limited to in a surgical setting. The embodimentsdisclosed herein further relate to guides for use with the drillingapparatus described in various embodiments, as well as for use withother apparatus.

In embodiments, the apparatus is for use with a customized orstandardized instrument, such as a drill. The instrument preferablycomprises a housing or body, a drill bit, which preferably extends outfrom the drill body, and has a length suitable for use in an open orminimally invasive surgical procedure. In embodiments, the drill bit hasa male/female groove or channel along its length, which is beneficialfor engaging one or more apparatus described in detail below.

In one aspect, the apparatus may be configured to selectively engagewith a drill bit and provide a hard stop for preventing travel of thedrill bit beyond a predetermined depth. In one aspect, the apparatus maybe easily removed and placed in another location for subsequentprocedures requiring a different depth.

In one aspect, the apparatus comprises a body portion and a collarportion, which may be joined together and secured relative to each otherand to the drill bit in a locked or unlocked position. In embodiments,the locked and unlocked positions are visible from indicia placed on oneor more of the body portion and the collar portion.

In another aspect, the apparatus comprises only a body portion andfunctions in a similar way as the embodiment comprising a collarportion. In yet another aspect, the apparatus does not comprise alocking feature.

In another aspect, the apparatus is placed along a helical channel on aninstrument, such as a drill bit. The helical channel is oriented in theopposite or reverse direction as the cutting blades or edges on thedrill bit, which in conjunction with the apparatus prevents the drillbit from over-penetrating if the apparatus becomes loose from the drillbit during use. In preferred embodiments, the apparatus may beselectively configured relative to a desired location along the lengthof a cutting or drilling bit, and locked to prevent the drill bit fromextending through a guide (or other device allowing movement of thecutting or drilling bit but not the apparatus) beyond the placement andconfiguration permitted by the securing of the apparatus on the cuttingor drilling bit. In this configuration, once the drill bit reaches thepre-determined depth, the drill will stop and not proceed further,thereby preventing over-travel. In other embodiments, the helicalchannel is oriented in the same direction as the cutting blades or edgeson the cutting instrument.

In another aspect, the apparatus comprises a viewing window or viewportfor reading indicia along the cutting instrument, such as the depth in adesired dimension.

In yet another aspect, the cutting instrument channel comprises aplurality of detents, which interface with a corresponding surface,herein referred to as “ball”, on the tab of the body portion. Thedetents are preferably shaped in a congruent manner to the ball, whichallow the apparatus to be secured to the shaft of the cuttinginstrument.

In one aspect the ball is a spherical shape. In other aspects the ballis rectangular, trapezoidal, cylindrical, etc.

According to another aspect, the drill bit comprises indents at fixedlocations corresponding to one or more preconfigured depths.

According to another aspect, the apparatus comprises a protrusion orother interior profile that creates a press-fit or frictional engagementwith a drill bit, such as a bit comprising a standard, smoothcylindrical shaft. Accordingly, the drill bit may comprise: (a) noindent or groove; (b) one or more indents or grooves at fixed intervals;(c) a single linear indent or groove; or (d) a combination of theforegoing.

In one aspect, a linear groove along the longitudinal axis of the drillbit permits the apparatus to translate along the longitudinal axis whilepermitting a press fit or frictional engagement between the apparatusand the bit. As in previously described configurations, the thickness ofthe apparatus prevents over-insertion of the drill bit beyond thelocation of the apparatus, which a user may translate as desired untilfixed in a first, second or third position, for example.

In yet another aspect, the apparatus is permitted to rotate and therebytranslate longitudinally along the shaft of the cutting instrumentbetween detents such that a specific rotation of the apparatus equatesto an increase (or decrease, if rotated in the opposite direction) of aspecified distance. For example, according to one embodiment of thepresent disclosure, a ¼ turn (i.e., 90° rotation) of the apparatusrelative to the shaft of the cutting instrument may move the apparatusby 2 mm, thereby increasing or decreasing the allowable depth of thecutting instrument depending on the direction of rotation.

The apparatus may be used with patient-specific guides or standardguides. Pre-determined depths may be determined, for example, by usingCAD software, 3-dimensional models, or in certain embodiments from CT,CTA, MRI, and PET scans or x-rays of a particular patient.

Incorporated by reference in their entireties are the following U.S.patents and patent applications directed generally to methods andapparatus related to surgical procedures, thus providing writtendescription support for various aspects of the present disclosure. TheU.S. patents and pending applications incorporated by reference are asfollows: U.S. Pat. Nos. 7,957,824, 7,844,356, 7,658,610, 6,830,570,6,368,325, 3,486,505 and U.S. Pat. Pub. Nos. 2018/0042619, 2010/0217336,2009/0138020, 2009/0087276, 2008/0161817, 2008/0114370, and2007/0270875.

Additionally, U.S. Pat. Nos. 8,758,357, 8,870,889, 9,198,678 and9,642,633 are incorporated by reference for the express purpose ofillustrating systems and methods for creating a surgical or cuttingguide, such as the ones described herein, using additive manufacturingor other techniques, wherein the device incorporates one or morepatient-matched surfaces or is otherwise customized to a particularpatient.

The phrases “at least one,” “one or more,” and “and/or,” as used herein,are open-ended expressions that are both conjunctive and disjunctive inoperation. For example, each of the expressions “at least one of A, Band C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “oneor more of A, B, or C,” and “A, B, and/or C” means A alone, B alone, Calone, A and B together, A and C together, B and C together, or A, B andC together.

Unless otherwise indicated, all numbers expressing quantities,dimensions, conditions, and so forth used in the specification andclaims are to be understood as being approximations which may bemodified in all instances as required for a particular application ofthe novel apparatus described herein.

The term “a” or “an” entity, as used herein, refers to one or more ofthat entity. As such, the terms “a” (or “an”), “one or more” and “atleast one” can be used interchangeably herein.

The use of “including,” “comprising,” or “having” and variations thereofherein is meant to encompass the items listed thereafter and equivalentsthereof as well as additional items. Accordingly, the terms “including,”“comprising,” or “having” and variations thereof can be usedinterchangeably herein.

It shall be understood that the term “means” as used herein shall begiven its broadest possible interpretation in accordance with 35 U.S.C.,Section 112(f). Accordingly, a claim incorporating the term “means”shall cover all structures, materials, or acts set forth herein, and allof the equivalents thereof. Further, the structures, materials, or actsand the equivalents thereof shall include all those described in theSummary, Brief Description of the Drawings, Detailed Description,Abstract, and Claims themselves.

The Summary is neither intended, nor should it be construed, as beingrepresentative of the full extent and scope of the present disclosure.Moreover, references made herein to “the present disclosure” or aspectsthereof should be understood to mean certain embodiments of the presentdisclosure and should not necessarily be construed as limiting allembodiments to a particular description. The present disclosure is setforth in various levels of detail in the Summary as well as in theattached drawings and the Detailed Description, and no limitation as tothe scope of the present disclosure is intended by either the inclusionor non-inclusion of elements or components when describing certainembodiments herein. Additional aspects of the present disclosure willbecome more readily apparent from the Detailed Description, particularlywhen taken together with the drawings.

The above-described benefits, embodiments, and/or characterizations arenot necessarily complete or exhaustive, and in particular, as to thepatentable subject matter disclosed herein. Other benefits, embodiments,and/or characterizations of the present disclosure are possibleutilizing, alone or in combination, as set forth above and/or describedin the accompanying figures and/or in the description herein below.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutea part of the specification, illustrate embodiments of the disclosure,and together with the Summary and the Detailed Description serve toexplain the principles of these embodiments. In certain instances,details that are not necessary for an understanding of the disclosure orthat render other details difficult to perceive may have been omitted.It should be understood, of course, that the present disclosure is notnecessarily limited to the particular embodiments illustrated herein.Additionally, it should be understood that the drawings are notnecessarily to scale. In the drawings:

FIGS. 1A-1F show multiple views of the apparatus configured for assemblywith a cutting instrument according to embodiments of the presentdisclosure;

FIGS. 2A-2D show multiple views of the body of the apparatus accordingto embodiments of the present disclosure;

FIGS. 3A-3B show multiple views of the collar of the apparatus accordingto embodiments of the present disclosure;

FIGS. 4A-K show multiple views of the body and collar in an assembledstate according to embodiments of the present disclosure;

FIG. 5 shows a detailed view of a cutting instrument according toembodiments of the present disclosure;

FIG. 6 shows a partial sectional view of the body and collar of theapparatus relative to a cutting instrument according to embodiments ofthe present disclosure;

FIG. 7A shows a perspective view of the collar and body assembled withthe cutting instrument of FIG. 5 according to embodiments of the presentdisclosure;

FIG. 7B shows a perspective view of the collar and body assembled withthe cutting instrument of FIG. 5 according to alternate embodiments ofthe present disclosure;

FIGS. 8A-8E show various views of drill bits contemplated for use withthe collar and body according to embodiments of the present disclosure;

FIGS. 9A-9C show side elevation and sectional views of the collar andbody assembly according to embodiments of the present disclosure;

FIGS. 10A-D show various views of the apparatus according to yet anotherembodiment of the present disclosure; and

FIGS. 11A-C show various views of the collar and body assembled with thedrill bit of FIG. 8B in one embodiment of the present disclosure.

Similar components and/or features may have the same reference number.Components of the same type may be distinguished by a letter followingthe reference number. If only the reference number is used, thedescription is applicable to any one of the similar components havingthe same reference number.

DETAILED DESCRIPTION

The present disclosure has significant benefits across a broad spectrumof endeavors. It is the Applicant's intent that this specification andsubsequent claims be accorded a breadth in keeping with the scope andspirit of the disclosure and various embodiments disclosed, despite whatmight appear to be limiting language imposed by specific examplesdisclosed in the specifications. To acquaint persons skilled in thepertinent arts most closely related to the present disclosure, preferredand/or exemplary embodiments are described in detail without attemptingto describe all of the various forms and modifications in which thenovel apparatus, devices, systems and methods might be embodied. Assuch, the embodiments described herein are illustrative, and as willbecome apparent to those skilled in the arts, may be modified innumerous ways within the spirit of the disclosure.

By way of providing additional background, context, and to furthersatisfy the written description requirements of 35 U.S.C. § 112, thefollowing are incorporated by reference in their entireties for theexpress purpose of explaining and further describing the various toolsand other apparatus commonly associated therewith surgical procedures:U.S. Pat. No. 6,309,395 to Smith et al.; U.S. Pat. No. 6,142,998 toSmith et al.; U.S. Pat. No. 7,014,640 to Kemppanien et al.; U.S. Pat.No. 7,406,775 to Funk, et al.; U.S. Pat. No. 7,387,643 to Michelson;U.S. Pat. No. 7,341,590 to Ferree; U.S. Pat. No. 7,288,093 to Michelson;U.S. Pat. No. 7,207,992 to Ritland; U.S. Pat. No. 7,077,864 Byrd III, etal.; U.S. Pat. No. 7,025,769 to Ferree; U.S. Pat. No. 6,719,795 toCornwall, et al.; U.S. Pat. No. 6,364,880 to Michelson; U.S. Pat. No.6,328,738 to Suddaby; U.S. Pat. No. 6,290,724 to Marino; U.S. Pat. No.6,113,602 to Sand; U.S. Pat. No. 6,030,401 to Marino; U.S. Pat. No.5,865,846 to Bryan, et al.; U.S. Pat. No. 5,569,246 to Ojima, et al.;U.S. Pat. No. 5,527,312 to Ray; and U.S. Pat. Appl. No. 2008/0255564 toMichelson.

Several advantages of an improved depth control apparatus havepreviously been described herein, but for convenience, the followingadvantages are contemplated by this disclosure: customizable apparatusfor use with a specific or numerous different instruments, tools orother surgical equipment, including both motorized and non-motorized;materials that permit 3D printing or otherwise simplify the fabricationof the components of the apparatus; reusability and/or disposability ofcomponents; ease of identification, orientation and establisheddepth/penetration of associated instruments; lockable and unlockableconfigurations; ease of assembly; inhibition or prohibition to rotate or“slip” once assembled; ease of adjustment to achieve different depths;pre-surgically assembled to decrease time of operation and associatedexposure to radiographic or other energy-emitting equipment; ease ofremoval; safety in that the device will not over penetrate if it becomesloose; and ability to use alone or in conjunction with patient-specificdevices as described in greater detail below.

Several views of the apparatus described herein are shown in FIGS.1A-7B. The apparatus of the present disclosure preferably employs twoprimary components or portions. The first portion is referred to hereinas the body portion 10 or simply “the body.” The second portion isreferred to herein as the collar portion 20 or simply “the collar.”These two components are configured to connect in a specific manner andin combination provide a depth stop or hard stop apparatus when used inconnection with a cutting instrument 30, such as a drill bit. In oneembodiment, the two components 10, 20 are assembled together in apress-fit connection to form a depth stop assembly. In otherembodiments, the body 10 and collar 20 portions are manufactured in apre-assembled configuration.

The depth stop assembly preferably interfaces with at least one guide,such as a cannula. This interface permits a surgeon or other user todetermine the “zero” location for a prescribed depth, vis-à-vis the atleast one guide. The apparatus of the present disclosure also preferablyinterfaces with at least one instrument, tool or other surgical devicethat allows the assembly to prevent penetration of the at least oneinstrument, tool or other surgical device beyond a specific depth ordistance. In embodiments, the instrument is a drill bit, although othercutting instruments are contemplated for use with the apparatus and aredescribed in further detail below.

In embodiments, the body 10 and collar 20 portions may be 3D printed outof a metal or plastic (including but not limited to steel, stainlesssteel, metal alloys, polyurethane, polyethylene, ABS, resin-basedmaterials, nylon or equivalent) material. In embodiments, the apparatusis intended to be single use. In other embodiments, the apparatus isreusable.

In embodiments, the depth stop assembly may lack a collar 20 portion butstill interfaces with a cutting apparatus. In this embodiment, the depthstop assembly does not include a lockable configuration.

An exploded view of the system is shown below in FIG. 1A. In thisembodiment, the collar 20 preferably couples to a first section of thebody 10. Then, the collar 20 and body 10 assembly (referred to herein as“the apparatus”) is then coupled to the cutting instrument 30 as shownin FIGS. 7A-7B. In alternate embodiments, the body 10 is coupled to thecutting instrument 30 and then the collar 20 portion is coupled to thebody 10 portion. As shown in FIG. 1A, the cutting instrument 30 maycomprise a male/female groove G or channel along at least a portion ofits length, and may further comprise one or more indicia I forindicating the associated depth or distance from a distal end of thecutting instrument 30, such as the sharpened tip of a drill bit, forexample. FIGS. 1B-1F show multiple elevation views of body 10 and collar20 portions in different relative positions and/or orientations whenassembled with the cutting instrument 30.

Referring now to FIGS. 2A-2D, several detailed view of the body 10 ofthe apparatus are shown. The body 10 is preferably generallycylindrical, although variations along the length of the body 10 arecontemplated and shown in FIG. 2A. In these embodiments, the body 10 maycomprise a first section having a smaller outer diameter 13 and a secondsection having a larger outer diameter 11. The larger outer diametersection 11 is preferably used to manipulate and/or position the depthstop assembly. This section 11 also preferably comprises ergonomicfeatures, such as a knurling 21 and/or thumb indentation 31 for improvedpurchase by a user's fingers and subsequent manipulation and use. Thespace for the thumb indentation 31 may also serve as a location of acut-out or marking window, which permits a user to align the markingwindow with indicia I on the cutting instrument 30, and which notifiesthe user the permissible depth of the instrument 30 in conjunction withthe depth stop apparatus.

The body 10 may also comprise an orientation viewport 41, which isfurther used to align the body 10 portion with markings on the collar 20portion, and/or to notify the user when the depth stop is locked orunlocked. The viewport 41 may be located and sized in a manner toprevent misreading indicia I on either the cutting instrument 30 or thecollar 20 inadvertently.

The first section of the body 13 may comprise a raised ridge 15, whichserves to assist with retaining the collar 20 once the components havebeen coupled together and the apparatus assembled. One or more reliefcuts 16 may be provided along the raised ridge 15 to aid in the assemblyprocess.

Referring now to FIG. 2B, the body 10 preferably comprises a bore orinner diameter 18 that runs through at least a portion of the first andsecond sections of the body. The inner diameter 18 preferably comprisesinternal threads 17, which match (i.e., in a male/female or female/malethreaded arrangement) the thread form of the cutting instrument 30. Theinternal threads 17 are preferably arranged substantially or completelyin a helical arrangement, which helps to keep the depth stop in thecorrect location, aids in controlling adjustment of depth incrementally,and prevents the apparatus from moving during use.

Referring to FIG. 2C, a keyway 19 is shown. This keyway 19 preferablymates with a key K on the collar 20, and which in turn controls and/orlimits the rotation of the collar 20 between the locked and unlockedpositions, which is described in greater detail below. The keyway 19 issized to receive the key K on the collar 20 in a congruent manner, suchthat the key K is not easily displaced from the keyway 19 once the body10 and collar 20 portions are joined together. A top plan view of thebody 10 is shown in FIG. 2D.

Referring now to FIGS. 3A-3B, the collar 20 portion of the apparatus isshown. Similar to the body 10, the collar 20 is preferably cylindrical(or generally cylindrical) and comprises a bore or inner diameter. Thecollar 20 portion preferably comprises a key K, which interfaces withthe keyway 19 of the body 10 portion as described above. The collar 20portion also preferably includes a “lock” and “unlock” graphic or otherindicia I, which when positioned in line with the orientation viewport41 of the body 10 will display to the user an “unlocked” or “locked”symbol or other indicia I corresponding to an unlocked or lockedapparatus. In embodiments, the orientation viewport 41 is substantiallyin the shape of an arrowhead or triangle, such that the leading point ofthe triangle points towards the pertinent indicia I. The collar 20 alsopreferably comprises knurling 14, which comprise surface features raisedlarger than the knurling 21 on the body 10. This difference in knurlingor other surface feature helps in identification of the two componentsby feel/touch when the apparatus is being assembled or is in use. Thecollar 20 preferably comprises a closed portion 51 where a ridge 15 ofthe body terminates once the two components are joined together.

Referring again to FIG. 2B, a tab 9 is preferably provided on the firstportion 13 of the body 10, which is designed to flex up and down as itcontacts a ball 100 (partially shown in FIG. 2C) situated under the tab9. This ball 100 is also moved in and out of detents preferably formedwithin the groove and along the length of the cutting instrument 30, asdescribed in greater detail below. When the collar 20 is rotated to thelocked position, the tab 9 is held down which results in the ball 100being retained in at least one detent formed along the groove of thecutting instrument 30, which locks the device. A ramp 12 on the tab 9aids in the transition between unlocked and locked as the collarrotates.

Referring again to FIG. 3A, the collar 20 portion also comprises an openor expanded portion 26, which allows for the tab 9 of the body 10 toflex outwardly into the expanded portion 26 of the collar 20 when thecollar 20 is in an unlocked position. The collar 20 also comprises aclosed portion 27, which prevents the tab 9 of the body 10 to flexoutward into the collar's expanded portion 26 when the collar 20 is in alocked position. A detent may be provided in the internal diameter ofthe collar 20 to further achieve this objective.

Referring to FIGS. 4A-4K, multiple views of the final assembled depthstop can be seen in the images below. These images include the lockedvs. unlocked orientations of the device. FIG. 4A shows the assembledapparatus in a perspective view. FIG. 4C shows a plan view of the collar20 portion in a locked orientation, and FIG. 4B shows a plan view of thecollar 20 portion in an unlocked orientation. FIGS. 4D-4G show elevationviews of the body 10 and collar 20 in an assembled configuration. FIGS.4H-4I show perspective views of the assembled apparatus, and FIGS. 4J-4Kshow additional views of the assembly.

In the preferred embodiment, the collar 20 is rotated on the body 10 toachieve the locked position of the tab 9. In other embodiments, thecollar 20 is slidable along the major axis of the body 10 to achieve thelocked position of the tab 9. In yet other embodiments, the collar 20 isfirst slidable along the major axis of the body 10 and is then rotatedto achieve the locked position of the tab 9.

Referring now to FIG. 5 , an instrument 30 for use with the apparatusdescribed above is shown. Here, a cutting instrument 30 preferablycomprises a helical male/female groove or channel G to facilitatecoupling with the apparatus and to control the depth of the depth stopapparatus. This channel G also facilitates retaining the depth stop inplace, and to orient the depth stop. In a preferred embodiment, thehelical grove G is the reverse direction (i.e., counterclockwise) inrelation to the cutting end of the instrument 30. This allows for thedrill bit to back out or reverse if the depth stop is jammed or lockedup and prevents the cutting instrument 30 from plunging deeper into thepatient when the cutting instrument 30 remains in the forward cuttingdirection. The helical grove G preferably comprises a specific pitch,such that a specific turn/rotation of the depth stop apparatus by aspecific amount results in the desired drill depth increment change. Ina preferred embodiment, a ¼ turn equates to a movement of 2 mm. Inanother embodiment the helical grove G is in the same direction inrelation to the cutting end of the instrument.

The cutting instrument 30 preferably comprises a plurality of detents Dalong the channel or groove G, which interface with the ball 100 (andthereby the tab 9) of the body 10 portion as described above. Thedetents D are preferably shaped and/or contoured in a congruent mannerto the spherical dimensions of ball 100.

The cutting instrument 30 preferably comprises one or more markings orindicia I, which are viewable from the marking window 41 escribed abovefor proper orientation of the depth stop to the desired depth. Theindicia I are preferably orientated such that, if the depth stop isjoined to the cutting instrument 30 in the reverse (i.e., improper)orientation, no markings will be visible within the marking window 41.

Referring now to FIG. 6 , a partial sectional view of the depth stopapparatus is shown relative to an exemplary cutting instrument 30 ortool. As can be seen in the profile of FIG. 6 , the tab 9 is sunk whilethe ball 100 is within one of the plurality of detents D describedabove. Alternatively, when the ball 100 is not within one of theplurality of detents D, the tab 9 will be raised. This is permitted evenwhen the collar 20 portion is joined to the body 10 portion, so long asthe tab 9 remains in the expanded portion 26 of the inner diameter ofthe collar 20.

Referring to FIGS. 7A-7B, the assembly of the body portion, collarportion and cutting instrument are shown. As shown, the collar 20 isoriented relative to the body 10 to indicate a “locked” position, andthe orientation viewport 41 is arranged to permit viewing of the indiciaI along the length of the cutting instrument 30. The assembly accordingto an alternate embodiment is shown in FIG. 7B.

Additional embodiments of the present disclosure are shown in FIGS.8A-E, 9A-C, 10A-D and 11A-C. In various configurations, the apparatusmay comprise a body that engages the cutting instrument, such as a drillbit, with a frictional, press fit or equivalent engagement. Theapparatus is best shown in FIGS. 9A-C and 10A-D, according to differentembodiments. Here, the apparatus comprises at least one projection,protrusion or tab T that may be pressed against the cutting instrumentshaft to create a frictional or press fit engagement. In embodiments,rotation or other manipulation of a collar portion of the apparatuscauses the tab T to press against the shaft of the drill bit in africtional (or equivalent) engagement. Thus, the apparatus (as describedabove) preferably has at least a first configuration that permitstranslation of the apparatus along the shaft of the cutting instrument,and at least a second configuration that frictionally (or equivalently)locks the location of the apparatus in place on the cutting instrument.

In certain embodiments, the surface area in contact between theapparatus and the cutting instrument is more expansive than oneprojection, protrusion or tab T, such as the embodiment shown in FIGS.10A-D. The material of the apparatus may be such as to promote africtional (or equivalent) engagement, including the materials listedabove.

According to other embodiments, the drill bit may comprise one or moreindents at fixed locations that correspond to one or more preconfigureddepths, as shown in FIGS. 8B-C and 11A-C. The apparatus may be the sameor equivalent to the body and collar configuration shown in FIGS. 1-7B,or may be similar to the embodiment shown in FIGS. 9A-C, per the user'spreference. Variations and sub-combinations of these arrangements isalso contemplated and within the scope of the claimed invention.

Referring now to FIG. 8D, the cutting instrument may comprise a lineargroove or indent that permits the apparatus to move (i.e., translate)along the length of the cutting instrument, and the user may press fitor frictionally fit the apparatus in place along any portion of thelinear groove. As shown in FIG. 8E, the cutting instrument mayalternatively comprise a combination of a linear groove and periodiccircumferential slots. Variations on these configurations is expresslycontemplated.

Accordingly, the apparatus may comprise a protrusion or other interiorprofile that creates a press fit or frictional engagement with a drillbit. The drill bit may comprise a standard, smooth cylindrical shaftsuch as is customarily available regardless of the manufacturer of thecutting instrument. The drill bit, according to various embodimentsdescribed herein and shown in the appended drawing figures, maycomprise: (a) no indent or groove; (b) one or more indents or grooves atfixed intervals; (c) a single linear indent or groove; or (d) acombination of the foregoing.

This assembly and apparatus provides several benefits of the prior art.For instance, the reverse orientation of the channel of the cuttinginstrument (in comparison to the orientation of the blade of the cuttinginstrument) ensures that if the connection between the apparatus and thecutting instrument becomes insecure, the effect is the cuttinginstrument is backed out of the guide. As another example, the apparatusmay be easily coupled to multiple cutting instruments in advance of thesurgery, and thereby achieve multiple cutting depths without having toremove and replace a cutting guide or hard stop to the shaft of thecutting instrument. As yet another example, the depth stop apparatusdescribed above comprises at least two projections. The first orientsthe depth stop along the track of the cutting instrument, and the secondconstrains the depth stop from moving from its intended position andalong the track of the cutting instrument. Additionally, the desireddepth or distance is controlled between detents in set increments(preferably 0.5-7 mm increments and more preferably 1-5 mm increments),as opposed to controlling depth by visual inspection or observation of adisplay, or requiring a secondary source to verify the depth.

The depth control apparatus and the above-described components may bemanufactured via additive manufacturing. The depth control apparatus maybe used in various orthopedic surgical procedures. In one embodiment,the depth control apparatus may be used in various spinal procedures inall approaches (anterior, direct lateral, transforaminal, posterior,posterior lateral, direct lateral posterior, etc.). Specific featuresdescribed herein can address certain surgical objectives, for examplerestoring lordosis, restoring disc height, restoring sagittal or coronalbalance, etc.

The apparatus described herein may then be fabricated by any method.Fabrication methods may comprise the use of a rapid prototyping machine,a 3D printing machine, a stereolithography (STL) machine, selectivelaser sintering (SLS) machine, or a fused deposition modeling (FDM)machine, direct metal laser sintering (DMLS), electron beam melting(EBM) machine, or other additive manufacturing machine.

According to an alternative embodiment, anatomical data may be obtainedfrom an ultrasonic or nuclear medicine scanning device. In yet anotheralternative embodiment, the data may be supplemented or merged with datafrom a bone density scanner to fabricate a device that is designed toremain in the patient after the surgical procedure is completed, oralternatively to achieve further control over the orientation of anydesired axes, particularly where the surgical procedure involvesinsertion of one or more implantable devices.

One having skill in the art will appreciate that embodiments of thepresent disclosure may have various sizes. The sizes of the variouselements of embodiments of the present disclosure may be sized based onvarious factors including, for example, the anatomy of the patient, theperson or other device operating with or otherwise using the apparatus,the surgical site location, physical features of the devices andinstruments used with the apparatus described herein, including, forexample, width, length and thickness, and the size of the surgicalapparatus.

One having skill in the art will appreciate that embodiments of thepresent disclosure may be constructed of materials known to provide, orpredictably manufactured to provide the various aspects of the presentdisclosure. These materials may include, for example, stainless steel,titanium alloy, aluminum alloy, chromium alloy, and other metals ormetal alloys. These materials may also include, for example, PEEK,carbon fiber, ABS plastic, polyurethane, polyethylene, photo-polymers,resins, particularly fiber-encased resinous materials rubber, latex,synthetic rubber, synthetic materials, polymers, and natural materials.

One having skill in the art will appreciate that embodiments of thepresent disclosure may be used in conjunction devices that employautomated or semi-automated manipulation. Various apparatus and implantsdescribed herein may be provided to facilitate or control the entrypoint, angular trajectory, height, and/or head orientation of a screw,for example. For example, the drill may include further attachments touse with taps, burrs, trials or other surgical tools and instruments.

Additional benefits of the systems and methods described herein includeimproving device fixation, and/or preventing unwanted contact betweendevices and patient anatomy (e.g. the patient's spinal cord). Thefurther use of methods described above, including the use of softwareanalytics, may further aid in determining screw placement andorientation to achieve the ideal screw placement and/or rod shape. Forexample, the use of various apparatus described herein to achievedesired screw placement and orientation in turn provides improvedalignment of a secondary device, such as a rod, with the screws heads.This benefit in turn allows the surgeon/user to achieve optimal sagittaland/or coronal alignment, which assists in rod placement and improvescorrection of the patient's anatomy.

While various embodiments of the present disclosure have been describedin detail, it is apparent that modifications and alterations of thoseembodiments will occur to those skilled in the art. However, it is to beexpressly understood that such modifications and alterations are withinthe scope and spirit of the present disclosure. For furtherillustration, the materials provided in the provisional patentapplication from which this application claims priority to, includingAppendix A thereto, are expressly made a part of this disclosure andincorporated by reference herein in their entirety.

It is expressly understood that where the term “patient” has been usedto describe the various embodiments of the disclosure, the term shouldnot be construed as limiting in any way. For instance, a patient couldbe either a human patient or an animal patient, and the apparatus andmethods described herein apply equally to veterinary science as theywould to surgical procedures performed on human anatomy. The apparatusand methods described herein therefore have application beyond surgicalprocedures used by spinal surgeons, and the concepts may be applied toother types of “patients” and procedures without departing from thespirit of the present disclosure.

The foregoing discussion of the disclosure has been presented forpurposes of illustration and description. The foregoing is not intendedto limit the disclosure to the form or forms disclosed herein. In theforegoing Detailed Description for example, various features of thedisclosure are grouped together in one or more embodiments for thepurpose of streamlining the disclosure. This method of disclosure is notto be interpreted as reflecting an intention that the claimed disclosurerequires more features than are expressly recited in each claim. Rather,the inventive aspects lie in less than all features of a singleforegoing disclosed embodiment.

The present inventions, in various embodiments, include components,methods, processes, systems and/or apparatuses substantially as depictedand described herein, including various embodiments, subcombinations,and subsets thereof. Those of skill in the art will understand how tomake and use the present inventions after understanding the presentdisclosure. The present inventions, in various embodiments, includeproviding devices and processes in the absence of items not depictedand/or described herein or in various embodiments hereof, including inthe absence of such items as may have been used in previous devices orprocesses, e.g., for improving performance, achieving ease and/orreducing cost of implementation.

Moreover, though the present disclosure has included description of oneor more embodiments and certain variations and modifications, othervariations and modifications are within the scope of the disclosure,e.g., as may be within the skill and knowledge of those in the art,after understanding the present disclosure. It is intended to obtainrights which include alternative embodiments to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter.

What is claimed is:
 1. An apparatus configurable to contact and besecured to an instrument, the apparatus comprising: a body comprising atleast a first portion and a second portion, the first portion having asmaller radial dimension than the second portion, the body furthercomprising a bore passing through the longitudinal axis of the body forreceiving at least a certain length of the instrument, wherein the borecomprises at least one surface configured to engage at least a portionof the instrument; and a collar comprising a bore passing through itslongitudinal axis and selectively engageable with the body by placementof the first portion of the body in the bore of the collar, the collarselectively positionable about the body to include both a firstposition, wherein the at least one surface does not engage theinstrument, and a second position, wherein the at least one surface doesengage the instrument.
 2. The apparatus of claim 1 wherein the at leastone surface configured to engage at least one portion of the instrumentis a frictional engagement.
 3. The apparatus of claim 1, wherein theinstrument comprises a substantially cylindrical shaft.
 4. The apparatusof claim 3, wherein the instrument comprises a substantially smoothshaft.
 5. The apparatus of claim 3, wherein the instrument comprises alinear groove running substantially the entire length of the shaft. 6.The apparatus of claim 3, wherein the instrument comprises a pluralityof circumferential slots along the length of the shaft.
 7. The apparatusof claim 3, wherein the instrument comprises both a linear grooverunning substantially the entire length of the shaft and a plurality ofcircumferential slots along the length of the shaft.
 8. The apparatus ofclaim 1 wherein the instrument is a drill bit, a bur, a tap, a probe, areamer, or an implant.
 9. The apparatus of claim 1 wherein a specifiedtranslation of the apparatus relative to the instrument relates to aspecified depth the instrument may be inserted into a tube or guide. 10.The apparatus of claim 1 wherein the collar further comprises aplurality of indicia, including a first indicia representing a lockedposition of the apparatus and a second indicia representing an unlockedposition of the apparatus.
 11. The apparatus of claim 1 wherein the bodyfurther comprises a marker for visually identifying the position of thecollar relative to the body.
 12. The apparatus of claim 1 wherein thebody or the collar further comprises surface features for improving theplacement of a user's finger and manipulation of the body or the collar.13. The apparatus of claim 1 wherein the body and collar are formed of astainless steel, a titanium alloy, an aluminum alloy, a chromium alloy,a metal alloy, a PEEK material, a carbon fiber, an ABS plastic, apolyurethane, a polyethylene, a photo-polymer, a resin, a fiber-encasedresinous material, a rubber material, a latex material, a syntheticrubber, a synthetic material, a polymer, or a natural material.
 14. Anassembly, comprising: a depth stop configurable to contact and besecured to the cutting instrument, a cutting instrument, comprising abody with at least one groove formed to interface with the depth stop;the depth stop comprising a body with at least a first portion and asecond portion, the first portion having a smaller radial dimension thanthe second portion; the depth stop further comprising a collar with abore passing through its longitudinal axis and selectively engageablewith the body by placement of the first portion of the body in the boreof the collar, the bore comprising at least one expanded section havinga radial dimension greater than the remainder of the bore and furthercomprising at least one detent that is selectively engageable with thecutting instrument; wherein the at least one detent of the body furthercomprises at least one tab configured to be displaced radially when thecollar is rotated from a first position to a second position, thedisplacement of the tab increases contact of the at least one detentwith the cutting instrument; wherein the depth of the surgicalinstrument assembly is adjustable such that the first position of thecollar allows for unrestricted movement between the depth stop and thecutting instrument and the second position of the collar restrictsmovement of the depth stop and the with the instrument.
 15. The assemblyof claim 14 wherein the depth stop further comprises at least oneprojection, wherein the at least one projection is configured to contactthe at least one groove of the cutting instrument.
 16. The assembly ofclaim 15 wherein the at least one projection is formed along the bore ofthe body and is arranged in a substantially helical shape.
 17. Theassembly of claim 15 wherein the at least one projection is formed alongthe bore of the body and is arranged in a substantially linear shape.18. The assembly of claim 14 wherein the cutting instrument is a drillbit, a bur, a tap, or a reamer.
 19. The assembly of claim 14 wherein theat least one groove of the cutting instrument is arranged in asubstantially helical shape.
 20. The assembly of claim 14 wherein the atleast one groove of the cutting instrument is arranged in asubstantially linear shape.